This extensively revised new edition comprehensively reviews the rise of clinical research informatics (CRI). It enables the reader to develop a thorough understanding of how CRI has developed and the evolving challenges facing the biomedical informatician in the modern clinical research environment. Emphasis is placed on the changing role of the consumer, and the need to merge clinical care delivery and research as part of a changing paradigm in global healthcare delivery.

Introduction.- Section I: Contexts of Clinical Research Informatics.- From Notations to Data: The Digital Transformation of Clinical Research.- The Clinical Research Environment.- Methodological Foundations of Clinical Research.- Informatics Approaches to Participant Recruitment.- The Evolving Role of Consumers.- Clinical Research in the Post-genomic Era.- Section II: Data Management and Systems in Clinical Research.- Clinical Research Information Systems.- Study Protocol Representation.- Data Quality in Clinical Research.- Patient-Reported Outcome Data.- Biobanking Challenges and Informatics Opportunities.- Laboratory Data.- Patient Registries.- Knowledge Representation and Discovery.- Section III: Knowledge Representation and Ontologies.- Non hypothesis-driven Research: Data Mining and Knowledge Discovery.- Natural Language Processing, Electronic Health Records, and Clinical Research.- The Future of Clinical Research, Health, and Clinical Research Informatics.- Data Governance.- Data Sharing: Electronic Health Records and Research Interoperability.- Standards Development and the Future of Research Data Sources, Interoperability, and Exchange.- Pharmacovigilance.- Clinical Trials Registries and Results Databases.- Future Directions in Clinical Research Informatics.